A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Fluorouracil; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• adult patients >=18 years of age;

• metastatic colorectal cancer;

• >=1 target lesion;

• failed first-line chemotherapy with 5-fluorouracil and irinotecan.

Exclusion Criteria:

• previous treatment with oxaliplatin;

• progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;

• >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.